GlaxoSmithKline (GSK)’s B7-H3-targeted antibody-drug conjugate (ADC), GSK’227 has gained priority medicines (PRIME) designation from the European Medicines Agency (EMA) for the treatment of relapsed extensive-stage small-cell lung cancer (ES-SCLC).

It follows the breakthrough therapy designation awarded by the US Food and Drug Administration (FDA) in August 2024.

The EMA's decision is based on the early clinical outcomes from the ARTEMIS-001 study, an ongoing Phase I trial assessing safety, tolerability and initial anti-tumour efficacy in more than 200 patients.

The trial conducted by Hansoh Pharma assesses GSK’227 in subjects with locally advanced or metastatic solid tumours, including relapsed ES-SCLC.

GSK oncology research and development global head and senior vice-president Hesham Abdullah stated: “This PRIME designation is an important step forward as we seek to accelerate the development of GSK’227 in extensive-stage small-cell lung cancer and other tumour types with limited treatments.

“Our investigational B7-H3-targeted ADC is a key component of our broader ADC programme.”  

GSK has also commenced a Phase I global trial to support a registrational pathway for the therapy.

The company acquired exclusive global rights from Hansoh in early 2024 to progress the clinical development and commercialisation of GSK’227, except in mainland China, Hong Kong, Macau and Taiwan.

Also known as HS-20093, GSK’227 is a fully human anti-B7-H3 monoclonal antibody covalently linked to a topoisomerase inhibitor payload.

In addition to the ARTEMIS-001 study, HS-20093 is being investigated in multiple Phase I, II and III clinical trials across China for treating lung cancer, sarcoma, head and neck cancers, and other solid tumours.

In November 2024, GSK gained approval from Japan’s Ministry of Health, Labour and Welfare for its application to extend the indication of its respiratory syncytial virus (RSV) vaccine, Arexvy, for individuals aged 50 to 59 at increased risk.